Bexagliflozin 20 mg/1
Bexagliflozin · TABLET · Golden State Medical Supply, Inc.
Bexagliflozin is a tablet containing bexagliflozin at 20 mg/1, taken oral. Manufactured by Golden State Medical Supply, Inc..
Key Facts
- Brand Name
- Bexagliflozin
- Generic Name
- Bexagliflozin
- NDC Code (Product)
51407-918- Manufacturer
- Golden State Medical Supply, Inc.
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA214373
- Drug Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Marketing Start
- 01/20/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended dose: 20 mg once daily, taken in the morning, with or without food. Do not crush or chew the tablet. ( 2.2 ) • Assess renal function before initiating bexagliflozin tablets and as clinically indicated. Correct volume depletion before initiating ( 2.1 ) • Not recommended if eGFR less than 30 mL/min/1.73 m 2 . ( 2.1 ) • Withhold bexagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting ( 2.3 ). 2.1 Testing Prior to Initiation and During Treatment with Bexagliflozin Tablets • Assess renal function prior to initiation of bexagliflozin tablets and periodically thereafter as clinically indicated [see Warnings and Precautions ( 5.3 )] . Bexagliflozin is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 • Assess volume status. In patients with volume depletion, correct this condition before initiating bexagliflozin tablets [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.5 , 8.6 )]. 2.2 Recommended Dosage • The recommended dosage of bexagliflozin tablets is 20 mg orally taken once daily in the morning, with or without food [see Clinical Ph…
Contraindications
4 CONTRAINDICATIONS Bexagliflozin tablets are contraindicated in patients: With hypersensitivity to bexagliflozin or any excipient in bexagliflozin tablets. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors. • Hypersensitivity to bexagliflozin or any excipient in bexagliflozin tablets
Drug Interactions
7 DRUG INTERACTIONS See Table 4 for clinically significant interactions with bexagliflozin tablets. Table 4. Clinically Significant Interactions with Bexagliflozin Tablets UGT Enzyme Inducers Clinical Impact UGT Enzyme Inducers may significantly reduce exposure to bexagliflozin and lead to a decreased efficacy [ see Clinical Pharmacology ( 12.3 )]. Intervention Consider adding another antihyperglycemic agent in patients who require additional glycemic control. Concomitant Use with Insulin and Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when bexagliflozin tablets are used in combination with insulin and/or an insulin secretagogue. Intervention A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with bexagliflozin tablets. Lithium Clinical Impact Concomitant use with SGLT2 inhibitors such as bexagliflozin tablets may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently upon bexagliflozin tablets initiation and discontinuation. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions ( 5.1 )] Lower Limb Amputation [see Warnings and Precautions ( 5.2 ) ] Volume Depletion [see Warnings and Precautions ( 5.3 )] Urosepsis and Pyelonephritis [see Warnings and Precautions ( 5.4 )] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions ( 5.5 )] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions ( 5.6 )] Genital Mycotic Infections [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence > 5%) are female genital mycotic infections, urinary tract infection and increased urination ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact the bexagliflozin information line at 1-855-273-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates i…
Frequently Asked Questions
What is Bexagliflozin used for?
Bexagliflozin contains Bexagliflozin. It is a tablet taken oral. Consult your doctor for specific uses.
Is Bexagliflozin a controlled substance?
Bexagliflozin is not classified as a controlled substance by the DEA.
What is the generic name for Bexagliflozin?
The generic name for Bexagliflozin is Bexagliflozin. There are 1 other brand versions of Bexagliflozin.
What is the NDC code for Bexagliflozin 20 mg/1?
The NDC (National Drug Code) for Bexagliflozin 20 mg/1 is 51407-918, listed by Golden State Medical Supply, Inc..